Disclosed are devices and methods related to treatment of obesity in animals or humans, and more particularly to reducing the appetite of a person being treated for obesity.
Obesity is a global disease that affects more than hundreds of millions people worldwide. Obesity causes or contributes to numerous serious medical conditions including type 2 diabetes, hypertension, cardiovascular disease, arthritis, sleep apnea, and certain types of cancer. Approximately 22 million adults in the U.S. are considered morbidly obese (BMI>35) and another 50 million are obese (BMI>30). Contributing to 120,000 deaths each year, obesity is considered the second leading cause of preventable death after smoking. In fact, obesity is more damaging to an individual's health than smoking and alcohol abuse.
The costs associated with obesity are enormous, with an estimated annual treatment cost exceeding $238 billion, of which roughly $100 billion is devoted to treating related health problems. Additionally, Americans spend $33 billion each year on weight-loss products and services. It is not commonly appreciated that individual weight-related costs can amount to more than $15,000 a year per person.
The most common treatments for obesity—diet, exercise and pharmacologic therapy—have poor long-term success rates. Obesity surgery, which entails surgical restriction of the size of the stomach with or without re-routing the intestine to cause malabsorption, has been proven to be the only effective means of achieving sustainable weight loss in obese patients. While the current surgical treatments for obesity are effective, they are expensive, major procedures involving irreversible reconstruction of gastrointestinal anatomy or surgically placed implants. Many patients who could benefit from those procedures forgo surgery due to the significant complications and long-term adverse event rates associated with those procedures.
Other approaches include intra gastric balloons, which are silicone balloons that are placed in the stomach and filled with liquid or gas. These balloons have been used for years to help people lose weight by limiting the amount of food that they can eat before filling the stomach and feeling full.
There are, however, numerous problems with those balloon devices including: They must be placed by a doctor using a catheter; they break down over time (6 months) and must be removed by a doctor with a catheter; the user has very little control over the amount of weight that is lost (e.g., the balloons are non-adjustable); once removed the user typically regains their weight; if they pop or break, they can occlude the digestive track leading to significant injury and additional surgery to correct.
The devices and methods disclosed herein solve the problem of a weight loss regimen that is safe, controllable, and without any surgical invention by providing a swallowable self-expanding gastric space occupying device made from base constituents that are sized to ensure that while the whole device cannot pass out of the stomach the constituents that make up the device can pass. Controlled degradation of the device in the stomach into base constituents that are smaller than the whole by forming a composite membrane ensures safe and efficient excretion of the device after a well-defined time in the gastric environment.